Tayada Wacan ee Warshada Tooska ah Pregabalin 148553-50-8
Alaabtamagac | Pregabalin |
La mid ah | 3-(Aminomethyl) -5-methyl-hexanoic acid |
CAS Maya. | 148553-50-8 |
Muuqashada | Caddaan ilaa caddaan budo ah |
Qaanuunka molecular | C8H17NO2 |
Miisaanka Molecular | 159.23 |
Codsiga | Darajada daawada ama ujeedada cilmi baarista |
Baakad | Sida ku cad codsigaaga |
Kaydinta | Ku kaydi weel cidhiidhi ah oo iftiin u adkaysta meel qabow |
WAXYAABAHA | HEERARKA | NATIIJADA |
Muuqashada | Budada cad ama ka baxsan | U hogaansama |
Aqoonsiga | A. Buuxiyay shuruudaha | U hogaansama |
B. IR: oo la mid ah Walxaha Tixraaca | U hogaansama | |
Wareeg gaar ah | +10.0°~+13.0° | +10.5° |
Chloride | ≤0.1% | U hogaansama |
Enantiomer | ≤0.3% | 0.01% |
Walaxda la xidhiidha | Pregabalin Lactam ≤0.3% | Lama ogaan |
Pregabalin Diacid ≤0.3% | Lama ogaan | |
Pregabalin Amide CI-6 ≤0.3% | Lama ogaan | |
Wasakh kasta oo aan la garanayn ≤0.2% | U hogaansama | |
Wadarta wasakhda ≤1.0% | 0.04% | |
Khasaare xagga qalajinta | In aan ka badnayn 0.5% | 0.16% |
Hadhaaga dabka | In aan ka badnayn 0.1% | U hogaansama |
Biraha culus | ≤0.002% | U hogaansama |
Haraaga dareerayaasha | Khamriga isopropyl ≤0.5% | Lama ogaan |
Tetrahydrofuran ≤0.072% | Lama ogaan | |
Ethyl acetate ≤0.5% | Lama ogaan | |
Ethanol ≤0.5% | Lama ogaan | |
Qiimayn | 98.5% ~ 102.0% | 99.9% |
Macluumaadka Shirkadda
√ Waayo-aragnimada buuxda ee lakabka maamulka ee warshadda iyo farsamayaqaannada raacsan; √ Tayada had iyo jeer waa tixgelinteena ugu sareysa, nidaamka QC adag; √ 11 sano oo khibrad u leh kooxda iibka dhoofinta; √ shaybaadhka R&D ee madaxa banaan; √ Laba aqoon-is-weydaarsiyo GMP-dheer oo saxeexan; √ Khayraadka hodanka ah ee warshado badan oo shaqo la'aan ah oo loogu talagalay mashruuc la habeeyey; √ Kooxda shaqada oo hufnaan sare leh oo leh waddo joogto ah.Halkan ku qor fariintaada oo noo soo dir